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NCT05568719 · ClinicalTrials.gov registry record · Phase 3

Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively

A Phase 3 study of Hemophilia A and Hemophilia B, sponsored by Pfizer.

Recruiting
Registry status
Phase 3
Development phase
173
Enrollment target
16
Study locations

NCT05568719 is a Phase 3 study of Hemophilia A and Hemophilia B that is actively recruiting participants, run by Pfizer. The registered enrollment target is 173 participants, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (99% higher). The trial reports 16 study locations across 8 states.

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The verdict

NCT05568719, a Phase 3 study of Hemophilia A and Hemophilia B, is actively recruiting participants, sponsored by Pfizer.

RECRUITING
Registry status
Phase 3
Development phase
173 participants
Enrollment target
16
Study locations

Study Summary

A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.

Interventions

  • DIAGNOSTIC_TEST Testing of hepatic AAV Vector integration

Study Locations (16)

California

  • The Regents of the University of California||UC Davis Health - Rancho Cordova
  • UC Davis Health - Sacramento
  • UC Davis Ambulatory Care Clinic - Sacramento
  • UC Davis Hemophilia Treatment Center - Sacramento
  • UC Davis Medical Center - Sacramento
  • UCSF Outpatient Hematology Clinic - San Francisco

Florida

  • USF Health Morsani Center For Advanced Healthcare - Tampa
  • The University of South Florida Board of Trustees - Tampa

New York

  • Cornell University||Joan & Sanford I. Weill Medical College - New York
  • Weill Cornell Medical College-New York Presbyterian Hospital - New York

New South Wales

  • Royal Prince Alfred Hospital - Camperdown
  • Sydney Local Health District (RPAH Zone) - Camperdown

Mississippi

  • Mississippi Center For Advanced Medicine - Madison

Pennsylvania

  • The Childrens Hospital of Philadelphia Division of Hematology - Philadelphia

Washington

  • Washington Institute for Coagulation - Seattle

İ̇zmir

  • Ege Universitesi Hastanesi - Izmir

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2022-12-28
Est. Completion 2040-02-25
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT05568719

The ClinicalTrials.gov registry entry for NCT05568719 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (99% higher). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Testing of hepatic AAV Vector integration is the first listed.

NCT05568719 reports 16 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT05568719 about?

NCT05568719 is a clinical study titled "Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively". A study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participan...

What is the current status of trial NCT05568719?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2022-12-28. Estimated completion is 2040-02-25.

What conditions does trial NCT05568719 study?

This clinical trial studies the following conditions: Hemophilia A, Hemophilia B.

What interventions are being tested in trial NCT05568719?

The interventions under investigation include: Testing of hepatic AAV Vector integration (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05568719?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05568719 being conducted?

This trial has 16 study locations across California, Florida, Mississippi, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.